Clinical Trial FAQs

Who usually funds clinical trials?

Government agencies such as the National Institute of Health (NIH), the Department of Defense and the Department of Veterans Affairs usually fund clinical trials. In particular, the National Cancer Institute (NCI), a branch of the NIH, was created to research cancer and is the host of most clinical trials in the United States. Additionally, the NCI supports several clinical trial programs, including: the Cancer Centers Program, the Specialized Programs of Research Excellence (SPOREs) and the Cancer Trials Support Unit (CTSU), to name a few.

Aside from government agencies, both individuals and organizations can fund a clinical trial. An individual can include a physician with a particular interest in the disease or a family member of a loved one that is afflicted by the disease. Organizations usually include hospitals, pharmaceutical companies or foundations.

What are eligibility criteria, and why are they necessary?

Eligibility requirements will vary from trial to trial, according to the specific protocol. One of the most limiting factors involves treatment history but other restrictions may include age, staging of the disease and general medical history.

In the sense that a clinical trial is still an experiment, it is necessary that the restrictions for a trial limit the patient variance in order to make for more accurate results and conclusions.

Where do clinical trials take place?

Where a clinical trial is depends greatly on who is funding it. If it is funded by NCI or another government agency, it is likely that institutes across the nation are providing the clinical trial. Conversely, if just one physician or institute is the host, the clinical trial may just be accessible at one location.

What can one gain from participating in a clinical trial?

Before a clinical trial comes to fruition, there must be a lot of concrete evidence on the effectiveness of the treatment option. Therefore, especially for those patients who have run out of treatment options, a clinical trial may be the best chance for an improved quality of life. Additionally, to ensure the most effective outcome of the clinical trial, patients will receive thorough checkups and medical care. Most importantly, participation in a clinical trial may significantly benefit disease research, thereby contributing to the future outcomes of other patients.

What are some of the possible risks associated with taking part in a clinical trial?

New drugs and techniques may by ineffective, or less effective, than current standards or care. Because the treatments are new, doctors do not always know the side effects. In addition, even if a new approach has benefits, it may not work for you.

Who pays for the costs of the clinical trial?

More often than not, insurance companies will not cover the costs associated with a clinical trial. If they find that the trial is ‘experimental’, more expensive than the cost of standard treatment or not medically necessary, they will probably not cover the cost. However, some trials are considered ‘established’ and the insurance company will pay for them and others must be paid for by insurance per a legislative policy. Some of the more lenient insurance companies when it comes to clinical trials are Medicare, TRICARE and insurance through the Department of Veterans Affairs.

What questions should be posed to the clinicians before deciding to join a clinical trial?

Asking the questions below should help you stay informed about a clinical trial:

What is the study testing?

What research backs up the basis of the clinical trial?

What approval process has the trial gone through?

What are the potential benefits?

What are the potential risks?

How is data being collected and monitored?

How long will the trial last?

What does the trial involve? How often will there be testing and procedures? Are the procedures painful and/or time consuming?

Where will the testing and procedures take place?

Will the patient have to pay? Will insurance probably cover some or all of the costs?

What are the next steps after a clinical trial ends?

When a clinical trial ends, experts must review the data and determine whether the drug should go into the next phase of testing or be stopped due to unsafe conditions or ineffective results. Clinical trial results are oftentimes published in peer-reviewed, scientific journals before being published in public material. This allows for fellow experts and researchers to review the trial for accuracy and bias. Once it has been established that the trial is both safe and effective, the drug may become a standard treatment option for the disease in question.

Where can people find more information about clinical trials?

The following websites, most funded by the NCI, are excellent resources for additional information on clinical trials: